Shital Panchal
Austin,TX
Summary
To obtain a challenging position and utilize my educational background, interpersonal skills, and strong work ethic to benefit mutual growth and success with the company.
Overview
15
15
years of professional experience
Work History
Stay at Home Mom
12.2018 - Current
- Manage household operations, including budgeting, scheduling, and meal planning
- Organize and execute activities and educational outings to promote children's development
- Enhance multitasking, time management, problem-solving, and communication skills.
Remote Site Monitor- Full time
PPD part of Thermo Fisher Scientific
03.2015 - 12.2018
- Remotely reviewed EDC and drug accountability log
- Write, follow and resolved clinical queries and issues to ensure files were ready for audits
- Conducted remote investigation into site performance issues at directive of CTM
- Liaised with CRA to collect documents, review data points, and findings
- Ensured CTMS is updated per agreed study conventions
- Provided trial status tracking and progress update reports to CTM
- Provided refresher training, followed up on outstanding needs, updated study related trackers
- Reviewed and appropriately escalated site key risk/performance/quality indicators.
Research Coordinator Specialist-Full Time
PPD part of Thermo Fisher Scientific
07.2014 - 02.2015
- Provided administrative and technical support to Project Team
- Supported audit readiness by ensuring files are reviewed according to SOPs for study & PPD.
Regulatory Affairs Specialist- Full Time
Mckesson Specialty Health
09.2012 - 06.2014
- Oversaw and managed documentation of 30+ clinical trials
- Compiled trial specific regulatory documents and performed quality checks for audits
- Trained sponsors, CROs and new employees on policies and procedures
- Prepared protocol specific informed consents
- Submitted completed clinical study related documentation to IRB.
QC/QA Specialist Co-op in Research and Development Lab- Full Time
Bayer CropScience
05.2011 - 09.2012
- Lead 4 member team in testing of GMOs for specific desirable/undesirable traits
- Reviewed and practiced GLPs to ensure compliance
- Proficiency: LIMS workflow and data tracking software, lab automation, data analysis.
Certified Pharmacy Technician
Walgreens
11.2009 - 05.2011
- Received, verified, and prepared prescriptions
- Worked with insurance companies to resolve claims.
Education
Master of Science -
Texas Tech University
Lubbock, TX08.2012
Bachelor of Science -
Texas A&M University
College Station, TX05.2009
Skills
- MS Office
- MS Outlook
- Clinical Trial Management System
- Oncological Clinical Trails
- Life Sciences
- Medical Terminology
- LIMS
- EDC
Timeline
Stay at Home Mom
12.2018 - Current
Remote Site Monitor- Full time
PPD part of Thermo Fisher Scientific
03.2015 - 12.2018
Research Coordinator Specialist-Full Time
PPD part of Thermo Fisher Scientific
07.2014 - 02.2015
Regulatory Affairs Specialist- Full Time
Mckesson Specialty Health
09.2012 - 06.2014
QC/QA Specialist Co-op in Research and Development Lab- Full Time
Bayer CropScience
05.2011 - 09.2012
Certified Pharmacy Technician
Walgreens
11.2009 - 05.2011
Master of Science -
Texas Tech University
Bachelor of Science -
Texas A&M University
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